- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883046
The Acute Effects of Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull
May 28, 2023 updated by: Izzet Kirkaya, Bozok University
The Acute Effects of Pre-Exercise Isolated and Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull Performance: A Placebo-Controlled Study
The aim of this study was to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Method: Nineteen Sport Sciences Faculty students (Age 23.6±1.6 years, height 171±9.4
cm, weight 64.3±9.6 kg, fat percentage 20.5±7.3 %, BMI 21.7±2.4
kg/m2) participated and completed the intervention.
This study was designed as crossover, double-blind and placebo-controlled.
Subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3).
For Caf conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules.
As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate dissolved in water.
For the combined condition, (Caf+NaHCO3), intake was set at 6 mg of caffeine and 0.3 g of sodium bicarbonate per kilogram of body weight.
All supplements were consumed 60 min before the tests.
Two submaximal trials of IMTP were performed at increasing intensities for 5 seconds (approximately %40-60 and %60-80 of their individually perceived 1RM, respectively, with 60-second rest intervals).
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tepebasi
-
Eskişehir, Tepebasi, Turkey, 26555
- Faculty of Sport Sciences Eskisehir Technical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being physically active and healthy
- Did not use ergogenic supplements in the last 3 months
- Did not consume high doses of caffeine (≤120-170 mg/d) were included in this study
Exclusion Criteria:
- Actively using supplements
- Did not perform maximal effort during performance tests
- Not using the supplements in the correct dose or vomiting after use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Baseline
The control measurement was made as a baseline measurement without supplementation
|
No supplement conditions
|
|
Placebo Comparator: Placebo
During Placebo conditions, participants consumed 20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey).
|
20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey)
|
|
Experimental: Caffeine
For Caffeine conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules (Nature's Supreme® Caffeine)
|
All supplements were consumed 60 min before the isometric mid-thigh pull tests, to reach peak blood concentrations at evaluation time.
Immediately after consumption, both Control and intervention participants rested in a quiet laboratory environment (Eskişehir Technical University, Laboratory of Human Athletic Performance), until the strength tests.
Participants were previously informed verbally and in writing that they should abstain from caffeine consumption (any caffeine-containing beverages and foods, such as coffee or tea, energy drinks, cocoa and cocoa-containing foods, chocolate and chocolate-containing foods or caffeine-containing drugs) for at least 24 hours before
|
|
Experimental: NaHCO3
As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate (Alfasol®, Kimbiotek, Turkey) dissolved in water
|
All supplements were consumed 60 min before the isometric mid-thigh pull tests, to reach peak blood concentrations at evaluation time.
Immediately after consumption, both Control and intervention participants rested in a quiet laboratory environment (Eskişehir Technical University, Laboratory of Human Athletic Performance), until the strength tests.
Participants were previously informed verbally and in writing that they should abstain from caffeine consumption (any caffeine-containing beverages and foods, such as coffee or tea, energy drinks, cocoa and cocoa-containing foods, chocolate and chocolate-containing foods or caffeine-containing drugs) for at least 24 hours before
|
|
Experimental: Combined
For the combined condition, (Caf+NaHCO3), 6 mg/kg of caffeine and 0.3 g/kg of sodium bicarbonate per kilogram of body weight of participants were consumed, after being dissolved together in water
|
All supplements were consumed 60 min before the isometric mid-thigh pull tests, to reach peak blood concentrations at evaluation time.
Immediately after consumption, both Control and intervention participants rested in a quiet laboratory environment (Eskişehir Technical University, Laboratory of Human Athletic Performance), until the strength tests.
Participants were previously informed verbally and in writing that they should abstain from caffeine consumption (any caffeine-containing beverages and foods, such as coffee or tea, energy drinks, cocoa and cocoa-containing foods, chocolate and chocolate-containing foods or caffeine-containing drugs) for at least 24 hours before
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isometric Mid-Thigh Pull (IMTP)
Time Frame: immediately after the intervention
|
to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2022
Primary Completion (Actual)
March 8, 2022
Study Completion (Actual)
March 12, 2022
Study Registration Dates
First Submitted
May 19, 2023
First Submitted That Met QC Criteria
May 28, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 28, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BozokU-SBF-IK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data presented in this study are available on website https://osf.io/r6uz2/
with Identifier: 10.17605/OSF.IO/R6UZ2
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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